Recall Z-0144-2011 ยท IZI System, X-Ray, Angiographic
Siemens Medical Solutions USA, Inc
AXIOM Artis Systems VB23A-VB23H with Perivision functionality, Model Numbers: 5904433,5904649, 5904466, 5904441, 5904656, 7728350, and 7007755 Angiographic X-ray System
| Date | Oct 26, 2010 (initiated Sep 9, 2010) |
| Status | Terminated |
| Reason | Sporadic system crash while Perivision is performed. |
| Root cause | Software design |
| Action | Siemens issued an Urgent Field Safety Notice to all customers. The letter informed customers of the potential issues and provided additional information on the implemented resolution. To resolve the problem, a system update was to be installed on each affected system under Update Instructions AX054/10/S. For questions phone (610) 448-3237. |
| Quantity | 286 units |
| Distribution | USA - Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K021021 | MODULAR ANGIOGRAPHY SYSTEM AXIOM ARTIS Siemens Medical Solutions USA, Inc., Jun 6, 2002 |